Pain Associated With Intrauterine Device InsertionNCT07854015
LI4 Acupuncture for Pain During Intrauterine Device Insertion
A study testing LI4 Acupuncture in people with Pain Associated With Intrauterine Device Insertion, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
This study will evaluate whether acupuncture can reduce pain during intrauterine device (IUD) insertion. Women undergoing IUD insertion will be randomly assigned to receive either real acupuncture at the LI4 point on both hands or a sham acupuncture procedure that does not penetrate the skin. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Associated With Intrauterine Device Insertion
- What is being tested?
- LI4 Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-50 years
- Scheduled to undergo copper intrauterine device (IUD) insertion for contraception
- Able to communicate in Turkish
- Able to understand and use the Visual Analog Scale (VAS) for pain assessment
- Able and willing to provide written informed consent
Who cannot join
- Confirmed or suspected pregnancy
- Active pelvic infection
- Unexplained abnormal uterine bleeding
- Any contraindication to IUD insertion
- Use of opioid analgesic or sedative medication within the preceding 24 hours
- Known allergy or hypersensitivity to acupuncture needle materials
Show all 12Show fewer
- Needle phobia
- Infection, wound, or other significant skin lesion at or near the acupuncture site
- Serious psychiatric disorder or cognitive impairment that may interfere with pain assessment or study participation
- Neurological disease or sequelae that may interfere with pain perception or pain assessment
- Requirement for an emergency procedure
- Previous participation in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Niğde Ömer Halisdemir University Hospital
Niğde, Niğde Province, 51240
Pınar Erdoğan, 05233646954, drpinarerdogan@gmail.com
About this study
Official title: Effect of Acupuncture at the LI4 Point on Pain During Intrauterine Device Insertion: A Sham-Controlled Randomized Clinical Trial
This study will evaluate whether acupuncture can reduce pain during intrauterine device (IUD) insertion. Women undergoing IUD insertion will be randomly assigned to receive either real acupuncture at the LI4 point on both hands or a sham acupuncture procedure that does not penetrate the skin. Both interventions will be applied for 15 minutes before IUD insertion. Participants will not know which treatment they receive. The clinician performing the IUD insertion and the researcher assessing the outcomes will also be unaware of the treatment assignment. Pain will be measured at different stages of the IUD insertion procedure and shortly after the procedure. The main outcome will be the highest pain score reported during IUD insertion. The study will also assess procedure tolerance, patient satisfaction, need for additional pain medication, and adverse events.
Read the detailed description
Pain during intrauterine device (IUD) insertion may affect procedure tolerance and patients' experience with this highly effective contraceptive method. Although several pharmacological approaches have been investigated for pain control during IUD insertion, their effectiveness has been inconsistent, and there is no universally accepted analgesic approach.
LI4 (Hegu) is an acupuncture point commonly used for analgesia. In a previous randomized controlled trial conducted by the investigators, bilateral LI4 acupuncture before IUD insertion was associated with lower post-procedural pain scores compared with no intervention. However, the absence of a sham control in that study did not allow specific effects of acupuncture to be distinguished from placebo and other nonspecific effects.
The present randomized, sham-controlled trial is therefore designed to evaluate the analgesic effect of bilateral LI4 acupuncture using a non-penetrating Park sham procedure as the comparator. The primary focus is pain experienced during the IUD insertion procedure. The sham-controlled and masked design is intended to reduce expectancy and assessment bias and provide a more rigorous estimate of the effect of LI4 acupuncture on procedure-related pain.
The IUD insertion procedure will be standardized across both study groups. No routine analgesic premedication will be administered before the procedure. IUD insertion will be performed according to the same standardized clinical protocol in all participants, including speculum placement, visualization of the cervix, tenaculum application, measurement of the uterine cavity, and IUD insertion. No analgesic medication will be routinely administered during the procedure. After completion of the scheduled pain assessments, an NSAID may be administered as rescue analgesia if clinically required, and its use will be recorded. Apart from the assigned acupuncture or sham acupuncture intervention, procedural management will be identical between the two groups.
- Being tested
- LI4 Acupuncture, Sham Acupuncture
- Keywords
- Acupuncture, LI4, Hegu, Intrauterine Device, IUD Insertion, Procedural Pain, Pain Management, Sham Acupuncture, Park Sham Device
- Medical subject headings
- Pain, Procedural, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LI4 AcupunctureProcedure or surgery
Bilateral acupuncture will be performed at the LI4 (Hegu) point 15 minutes before IUD insertion using sterile 0.25 × 25 mm acupuncture needles. Needles will be inserted to a depth of approximately 1.5-2 cm, and manual stimulation will be applied to elicit de qi. The needles will remain in place for 15 minutes and will then be removed before the IUD insertion procedure.
Sham AcupunctureProcedure or surgery
Bilateral sham acupuncture will be performed at the LI4 (Hegu) point 15 minutes before IUD insertion using Park-type non-penetrating sham needles. The sham needles will not penetrate the skin, and no de qi or manual stimulation will be elicited. The sham procedure will last 15 minutes and will be completed before IUD insertion. Treatment duration and participant-practitioner interaction will be standardized to match the LI4 acupuncture intervention.
| Study group | Role | What they receive |
|---|---|---|
| LI4 Acupuncture | Experimental | Participants assigned to this arm will receive bilateral acupuncture at the LI4 (Hegu) point 15 minutes before IUD insertion. Sterile 0.25 × 25 mm acupuncture needles will be inserted to a depth of approximately 1.5-2 cm. Manual stimulation will be applied to elicit de qi. The needles will remain in place for 15 minutes and will be removed before the IUD insertion procedure. Receives: Procedure: LI4 Acupuncture |
| Sham Acupuncture | Sham comparator | Participants assigned to this arm will receive bilateral sham acupuncture at the LI4 (Hegu) point using Park-type non-penetrating sham needles 15 minutes before IUD insertion. The sham needles will not penetrate the skin, and no de qi or manual stimulation will be elicited. The sham procedure will last 15 minutes and will be completed before the IUD insertion procedure, with the duration of treatment and participant-practitioner interaction standardized to match the LI4 acupuncture arm. Receives: Procedure: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Procedure-Related Pain During IUD Insertion
Pain will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), at three predefined procedural stages: tenaculum application, passage through the uterine cavity, and fundal placement of the IUD. For each participant, the highest VAS score recorded across these three stages will be defined as the maximum procedure-related pain score. Higher scores indicate greater pain.
Measured: During the IUD insertion procedure
Secondary outcomes (11)
Pain During Tenaculum Application
Pain will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), during tenaculum application. Higher scores indicate greater pain.
Measured: During tenaculum application
Pain During Passage Through the Uterine Cavity
Pain will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), during passage through the uterine cavity. Higher scores indicate greater pain.
Measured: During passage through the uterine cavity
Pain During Fundal Placement of the IUD
Pain will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), during fundal placement of the IUD. Higher scores indicate greater pain.
Measured: During fundal placement of the IUD
Pain at 3 Minutes After IUD Insertion
Pain will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain.
Measured: 3 minutes after completion of IUD insertion
Pain at 10 Minutes After IUD Insertion
Pain will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain.
Measured: 10 minutes after completion of IUD insertion
Occurrence of Vasovagal Reaction
Occurrence of a clinically observed vasovagal reaction associated with the IUD insertion procedure will be recorded as yes or no.
Measured: During IUD insertion and through 10 minutes after the procedure
Use of Rescue Analgesia
The need for rescue analgesic medication related to pain during or immediately after the IUD insertion procedure will be recorded as yes or no.
Measured: During IUD insertion and through 10 minutes after the procedure
Procedure Tolerance
Participants will rate their overall tolerance of the IUD insertion procedure using an 11-point numerical rating scale ranging from 0 (completely intolerable) to 10 (completely tolerable). Higher scores indicate better procedure tolerance.
Measured: 10 minutes after completion of IUD insertion
Patient Satisfaction
Participants will rate their overall satisfaction with the IUD insertion experience using an 11-point numerical rating scale ranging from 0 (not at all satisfied) to 10 (completely satisfied). Higher scores indicate greater satisfaction.
Measured: 10 minutes after completion of IUD insertion
Willingness to Choose the Same Method Again
Participants will be asked whether they would choose the same contraceptive method again based on their current IUD insertion experience. Responses will be recorded as yes or no.
Measured: 10 minutes after completion of IUD insertion
Pain Compared With Preprocedural Expectation
Participants will be asked to compare the pain experienced during IUD insertion with the pain they expected before the procedure. Responses will be categorized as less painful than expected, approximately as painful as expected, or more painful than expected.
Measured: 10 minutes after completion of IUD insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Associated With Intrauterine Device InsertionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Erdoğan, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854015
- Sponsor's protocol ID
- GETAT-IUD-LI4-01
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the results reported in the published article may be shared upon reasonable request to the corresponding author, following publication of the study results and subject to approval of the proposed use and applicable ethical and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture at the LI4 Point on Pain During Intrauterine Device Insertion: A Sham-Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07854015
- Acronym / sponsor ID
- GETAT-IUD-LI4-01
- Keywords
- Acupuncture, LI4, Hegu, Intrauterine Device, IUD Insertion, Procedural Pain, Pain Management, Sham Acupuncture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether acupuncture can reduce pain during intrauterine device (IUD) insertion. Women undergoing IUD insertion will be randomly assigned to receive either real acupuncture at the LI4 point on both hands or a sham acupuncture procedure that does not penetrate the skin. Both interventions will be applied for 15 minutes before IUD insertion. Participants will not know which treatment they receive. The clinician performing the IUD insertion and the researcher assessing the outcomes will also be unaware of the treatment assignment. Pain will be measured at different stages of the IUD insertion procedure and shortly after the procedure. The main outcome will be the highest pain score reported during IUD insertion. The study will also assess procedure tolerance, patient satisfaction, need for additional pain medication, and adverse events.
Detailed description
Pain during intrauterine device (IUD) insertion may affect procedure tolerance and patients' experience with this highly effective contraceptive method. Although several pharmacological approaches have been investigated for pain control during IUD insertion, their effectiveness has been inconsistent, and there is no universally accepted analgesic approach.
LI4 (Hegu) is an acupuncture point commonly used for analgesia. In a previous randomized controlled trial conducted by the investigators, bilateral LI4 acupuncture before IUD insertion was associated with lower post-procedural pain scores compared with no intervention. However, the absence of a sham control in that study did not allow specific effects of acupuncture to be distinguished from placebo and other nonspecific effects.
The present randomized, sham-controlled trial is therefore designed to evaluate the analgesic effect of bilateral LI4 acupuncture using a non-penetrating Park sham procedure as the comparator. The primary focus is pain experienced during the IUD insertion procedure. The sham-controlled and masked design is intended to reduce expectancy and assessment bias and provide a more rigorous estimate of the effect of LI4 acupuncture on procedure-related pain.
The IUD insertion procedure will be standardized across both study groups. No routine analgesic premedication will be administered before the procedure. IUD insertion will be performed according to the same standardized clinical protocol in all participants, including speculum placement, visualization of the cervix, tenaculum application, measurement of the uterine cavity, and IUD insertion. No analgesic medication will be routinely administered during the procedure. After completion of the scheduled pain assessments, an NSAID may be administered as rescue analgesia if clinically required, and its use will be recorded. Apart from the assigned acupuncture or sham acupuncture intervention, procedural management will be identical between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LI4 Acupuncture | Experimental | Procedure: LI4 AcupunctureParticipants assigned to this arm will receive bilateral acupuncture at the LI4 (Hegu) point 15 minutes before IUD insertion. Sterile 0.25 × 25 mm acupuncture needles will be inserted to a depth of approximately 1.5-2 cm. Manual stimulation will be applied to elicit de qi. The needles will remain in place for 15 minutes and will be removed before the IUD insertion procedure. |
| Sham Acupuncture | Sham comparator | Procedure: Sham AcupunctureParticipants assigned to this arm will receive bilateral sham acupuncture at the LI4 (Hegu) point using Park-type non-penetrating sham needles 15 minutes before IUD insertion. The sham needles will not penetrate the skin, and no de qi or manual stimulation will be elicited. The sham procedure will last 15 minutes and will be completed before the IUD insertion procedure, with the duration of treatment and participant-practitioner interaction standardized to match the LI4 acupuncture arm. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 18-50 years
- Scheduled to undergo copper intrauterine device (IUD) insertion for contraception
- Able to communicate in Turkish
- Able to understand and use the Visual Analog Scale (VAS) for pain assessment
- Able and willing to provide written informed consent
Key exclusion criteria (12 listed)
- Confirmed or suspected pregnancy
- Active pelvic infection
- Unexplained abnormal uterine bleeding
- Any contraindication to IUD insertion
- Use of opioid analgesic or sedative medication within the preceding 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LI4 AcupunctureBilateral acupuncture will be performed at the LI4 (Hegu) point 15 minutes before IUD insertion using sterile 0.25 × 25 mm acupuncture needles. Needles will be inserted to a depth of approximately 1.5-2 cm, and manual stimulation will be applied to elicit de qi. The needles will remain in place for 15 minutes and will then be removed before the IUD insertion procedure. | Procedure or surgery | LI4 Acupuncture |
| Sham AcupunctureBilateral sham acupuncture will be performed at the LI4 (Hegu) point 15 minutes before IUD insertion using Park-type non-penetrating sham needles. The sham needles will not penetrate the skin, and no de qi or manual stimulation will be elicited. The sham procedure will last 15 minutes and will be completed before IUD insertion. Treatment duration and participant-practitioner interaction will be standardized to match the LI4 acupuncture intervention. | Procedure or surgery | Sham Acupuncture |
Primary outcome
Maximum Procedure-Related Pain During IUD Insertion
Time frame: During the IUD insertion procedure
Pain will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), at three predefined procedural stages: tenaculum application, passage through the uterine cavity, and fundal placement of the IUD. For each participant, the highest VAS score recorded across these three stages will be defined as the maximum procedure-related pain score. Higher scores indicate greater pain.
11 secondary outcomes
Pain During Tenaculum Application
Time frame: During tenaculum application
Pain During Passage Through the Uterine Cavity
Time frame: During passage through the uterine cavity
Pain During Fundal Placement of the IUD
Time frame: During fundal placement of the IUD
Pain at 3 Minutes After IUD Insertion
Time frame: 3 minutes after completion of IUD insertion
Pain at 10 Minutes After IUD Insertion
Time frame: 10 minutes after completion of IUD insertion
Occurrence of Vasovagal Reaction
Time frame: During IUD insertion and through 10 minutes after the procedure
Use of Rescue Analgesia
Time frame: During IUD insertion and through 10 minutes after the procedure
Procedure Tolerance
Time frame: 10 minutes after completion of IUD insertion
Patient Satisfaction
Time frame: 10 minutes after completion of IUD insertion
Willingness to Choose the Same Method Again
Time frame: 10 minutes after completion of IUD insertion
Pain Compared With Preprocedural Expectation
Time frame: 10 minutes after completion of IUD insertion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the results reported in the published article may be shared upon reasonable request to the corresponding author, following publication of the study results and subject to approval of the proposed use and applicable ethical and institutional requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LI4 Acupuncture in people with Pain Associated With Intrauterine Device Insertion, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pınar Erdoğan, Assoc. Prof. (905233646954, drpinarerdogan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Procedure-Related Pain During IUD Insertion (time frame: During the IUD insertion procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.